In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches

AAPS Journal

Volumn 17, Issue 4, 2015, Pages 837-852

  Forbes, Ben ^a   Bäckman, Per ^b   Christopher, David ^c   Dolovich, Myrna ^d   Li, Bing V ^e   Morgan, Beth ^f  

^a KING'S COLLEGE LONDON   (United Kingdom)

^b ASTRAZENECA R AND D   (Sweden)

^c MERCK RESEARCH LABORATORIES   (United States)

^d MCMASTER UNIVERSITY   (Canada)

^e CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^f GLAXOSMITHKLINE   (United States)

Author keywords

aerosol; bioequivalence; deposition; dissolution; in vitro in vivo correlation; inhaler; regulatory; statistics and data analysis

Indexed keywords

AEROSOL; ARTICLE; BIOEQUIVALENCE; DECISION MAKING; DRUG APPROVAL; DRUG CLEARANCE; DRUG CONTROL; DRUG DELIVERY DEVICE; DRUG DISPOSITION; DRUG EXPOSURE; DRUG METABOLISM; DRUG PENETRATION; DRUG RESEARCH; DRUG SOLUBILITY; DRUG USE; HUMAN; IN VITRO IN VIVO CORRELATION; IN VITRO STUDY; IN VITRO TESTING; INVESTIGATIVE PROCEDURES; PARTICLE SIZE; PREDICTION; QUALITY CONTROL; STATISTICAL ANALYSIS; DRUG DESIGN; INHALATIONAL DRUG ADMINISTRATION; THERAPEUTIC EQUIVALENCE;

AEROSOL; DRUG;

ADMINISTRATION, INHALATION; AEROSOLS; DRUG APPROVAL; DRUG DESIGN; HUMANS; PHARMACEUTICAL PREPARATIONS; THERAPEUTIC EQUIVALENCY;

EID: 84931571234     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-015-9763-3     Document Type: Article

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